Residual Risk - idi ComfortFin IDI3000 Instrucciones De Uso

INSTRUCTIONS FOR USE
1 Instructions for Use:
Indication for Use:
Stirrups are used in a variety of surgical procedures including, but not limited to gynecology, urology,
laparoscopy, colorectal, general, and robotic surgery. These devices are capable of being used with
a broad patient population as deemed appropriate by the caregiver or institution.
Intended Use:
Stirrups are designed to position and support the patient's foot, lower leg and upper leg in a variety
of surgical procedures including, but not limited to gynecology, urology, laparoscopy, general and
robotic surgery. These devices are intended to be used by healthcare professionals within the
Operating Room setting.
Intended User and Patient Population:
Intended User: Surgeons, Nurses, Doctors, Physicians and/or Healthcare professionals involved in
the intended procedure utilizing the device. Not intended for Lay persons.
Intended Populations: This device is intended to be used with patients that do not exceed the
weight in the safe working load field specified in the product specification section 3.2.

Residual Risk:

This product complies with relevant performance, safety standards. However, device harm from
misuse, device damage, function or mechanical hazards cannot be completely excluded.
2 Safety Considerations:
Safety hazard symbol notice:
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE.
Equipment Misuse Notice:
Do not use the product if package is damaged or unintentionally opened before use. All
modifications, upgrades, or repairs must be performed by an authorized specialist.
Safe Disposal:
Customers should adhere to all federal, state, regional, and/or local laws and regulations as it
pertains to the safe disposal of medical devices and accessories.
If in doubt, the user of the device shall first contact IDI Technical Support for guidance on safe
disposal protocols.
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IFU Document Number: 03-0123-REV-E